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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. As this study was used as a read across the reliability was set to 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
[3-(trimethoxysilyl)propyl]urea
EC Number:
245-904-8
EC Name:
[3-(trimethoxysilyl)propyl]urea
Cas Number:
23843-64-3
IUPAC Name:
1-[3-(trimethoxysilyl)propyl]urea
Details on test material:
- Name of test material (as cited in study report): Y-11542
- Physical state: clear, colourless, viscous liquid
- Lot/batch No.: 2131UG060495
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2739-2903 g (2 males and 4 females)
- Housing: individual housing in suspended wire-mesh cages
- Diet: Purina Certified Rabbit Chow #5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 35-60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
6 (2 males, 4 females)
Details on study design:
TEST SITE
- Area of exposure: 2.4 cm²
- Type of wrap if used: 2-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape.

REMOVAL OF TEST SUBSTANCE
- Washing: wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight erythema were observed in 1 male and 1 female animal (grade 1) 24 h after begin of exposure until day 6. These slight erythema were accompagnied with desquamation which was fully reversible within 8 days. No edema reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 2), the structural analogue [3-(trimethoxysilyl)propyl]urea showed no irritating potential to the skin of rabbits.

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